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持続性/慢性原発性免疫血小板減少症の成人患者におけるTAK-079の試験

基本情報

NCT ID
NCT04278924
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
41
治験依頼者名
Takeda

概要

Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot. The main aim of the study is to check for side effects from taking TAK-079 at three different dose levels. Another aim is to learn if TAK-079 can increase the platelet count in people with ITP. In addition to receiving stable background therapy for ITP, participants will receive an injection of either TAK-079 or a placebo once a week for 2 months. A placebo looks like TAK-079 but will not have any medicine in it. After treatment, all participants will be followed-up for another 2 months. Then, participants who received TAK-079 will continue to be followed-up for an extra 4 months. Participants who received the placebo and would like to receive TAK-079 may be able to do this in an extension period in the study.

対象疾患

Primary Immune Thrombocytopenia

介入

Placebo(DRUG)
TAK-079(DRUG)

依頼者(Sponsor)

実施施設 (2)

社会福祉法人恩賜財団済生会支部東京都済生会 東京都済生会中央病院

Minato-Ku, Tokyo, Japan

学校法人日本大学 日本大学医学部附属板橋病院

tabashi City, Tokyo, Japan